Investigational Injectable for Episodic Migraine Decreased Monthly Migraine Days

Study results presented at the 2024 Annual Scientific Meeting of the American Headache Society (AHS) demonstrated a reduction in monthly migraine days for individuals with episodic migraine (EM) treated with ABP-450 (prabotulinumtoxinA; AEON Biopharma, Irvine, CA) vs placebo. 

The multicenter, randomized, double-blind, placebo-controlled, phase 2 study (NCT04845178) included participants with episodic migraine (EM) who had <15 headache days per month and between 6 and 14 monthly migraine days (MMDs) during the baseline run-in period (N=305). Participants were randomized 1:1:1 to receive ABP-450 150 units (U), ABP-450 195 U, or placebo. The primary endpoint was the mean change in MMDs from baseline to weeks 21–24, and the secondary efficacy endpoint was the percentage of patients achieving a reduction of ≥50% in MMDs from the 4-week baseline period to weeks 21–24. 

• There was no statistically significant difference in MMDs for those who received ABP-450: at weeks 21-24, the least squares mean reduction from baseline in MMDs was -4.8 days for the ABP-450 150 U dose treatment group and -5.0 days for the ABP-450 195U group compared to -4.2 days for the placebo group (P=.2844 and P=.1711, respectively). 
• Those randomized to receive ABP-450 195 U achieved a statistically significant reduction in MMDs: 69% of participants in the ABP-450 195 U group achieved a ≥50% reduction in MMDs compared with 52% in the placebo group reaching a ≥50% reduction (P=.0132).

The incidence of treatment emergent adverse events (TEAEs) was similar among the ABP-450 treatment and placebo groups.